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OpenTrials
Completed

NCT Number: NCT05240872

Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis

To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis

Completed

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Atasehir Florence Nightingale Hospital

Ataşehir, Istanbul, 34750, Turkey (Türkiye)

About this study

After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to web based block group randomization. Patients were evaluated prior to injection in terms of Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated measure ANOVA test used for statistical analysis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who were diagnosed with chronic plantar fasciitis
  • Nonresponded to o conservative treatment (stretching exercises, nonsteroidal anti-inflammatory drugs, and heel pads) for at least 6 weeks
  • Patient should be able to understand the informed consent about type of treatment and blindness and randomization
  • Visual analog scale pain higher than 5 (on a 10-point visual analog scale)

Exclusion criteria

  • previous history of any type of local injection treatment for heel pain
  • history of surgery for heel pain, foot and ankle disorders, fractures
  • Associated pathology involving the lower limb such as
  • tarsal tunnel syndrome
  • effusion of the ankle indicating an intra-articular disease
  • Peroneal/Achilles/tibialis tendons pathology
  • any obvious deformity of foot and ankle,
  • Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout
  • Pregnancy
  • Use of antiocoagulation -

Treatment and study plan

PRP injection

Biological

Plantar fascia injection therapy with PRP

ABI injection

Biological

ABI injection

Primary outcomes

  1. Changes in Visual Analogue Scale (VAS)

    Time frame: 0,1 st 3rd and 6th month; changes between time points will be assessed

    Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome

  2. Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score

    Time frame: 0,1 st 3rd and 6th month; changes between time points will be assessed

    American Orthopaedic Foot & Ankle Society (AOFAS) Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes Evaluation:0 worst 100 best

  3. Changes in Foot and Ankle Disability Index (FADI)

    Time frame: 0,1 st 3rd and 6th month; changes between time points will be assessed

    Foot and Ankle Disability Index Evaluation:0 worst 100 best

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

Is There Any Advantage of PRP Over Autologous Blood Injection in the Treatment of Chronic Plantar Fasciitis? A Prospective Randomized Double Blinded Study

Acronym: PF:AutovsPRP

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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